- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01606293
Use of Social Networking to Survey Women With Small and Large Cell Carcinomas of the Cervix
Objectives:
Primary: 1. To assess the feasibility of using social networking groups to survey patients with rare cancers.
Secondary:1. To elucidate the current means for diagnosis and treatment of women with small and large cell carcinomas of the cervix. 2. To evaluate anxiety regarding diagnosis, treatment, and recurrence among women with small and large cell carcinomas of the cervix.
Study Overview
Detailed Description
The entire study will be conducted electronically. A survey assessing presentation of disease, treatment history and follow-up (appendix A) will be hosted on a secured online server. In addition respondents will be asked to complete a battery of 40 questions assessing anxiety regarding their diagnosis and fear of recurrence based on previously published instruments (appendix B).
Patients will be asked to provide data on the presenting symptoms at the time of the diagnosis, method of diagnosis, HPV detection, modalities used as initial treatment, specialty of the physician administering the treatment, stage, follow up interval and diagnostic studies, recurrence free interval and treatments offered/received at the time of recurrence.
To assess anxiety and fear of recurrence we will be using questions from instruments initially used in a breast cancer population:
The Concerns About Recurrence Scale (CARS): The CARS has two main parts. In the first part, overall fear of recurrence is assessed with four questions addressing frequency, potential for upset, consistency, and intensity of fears. Participants rate each of these items on a 1-to-6 scale. In the second part, the nature of women's fears about recurrence is assessed with 26 items that follow the stem phrase: "I worry that a recurrence of cancer would" Participants use a 5-pointscale, ranging from 0 (not at all), to 1 (a little), to 2 (moderately), to 3 (a lot), and to 4 (extremely), to indicate the extent to which they worry about each item.
Lerman Cancer Worry Scale: This includes three items, one measuring the frequency of worrying about "getting recurrence cancer someday," and two items measuring the impact of worry on mood and performing daily activities. For cancer worry, subjects will rate their current levels of worry about getting cancer recurrence someday on a 5-point scale with points labeled not at all (1), rarely (2), sometimes (3), often (4), and almost all the time (5). For impact of worry on mood and on functioning, respondents experiencing cancer worries will rate the current impact of such worries on their moods and on their ability to perform their daily activities using a 4-point scale with points labeled not at all (I),a little (2), somewhat (3), and a lot (4).
The Survey will be offered to all patients who are members of the Facebook group found at the uniform resource locator https://www.facebook.com/SmallCellCC through an online link. We expect the survey to take participants 15-20 minutes to complete. Surveys with similar anxiety measuring elements conducted by phone and on the internet have been reported with success.
Patients will be presented with an online informed consent prior to taking the survey. In addition patients will be provided with an email address and a phone number to use if they have any questions or wish to withdraw from the study. Upon reading the informed consent patients will be able to proceed to the questionnaire hence signifying their informed consent or back to Facebook indicating their refusal. No personal identifying data will be collected. Prior to taking the survey they will be given a serial number to associate with their answers in case they wish to withdraw in the future.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Michael M. Frumovitz, MD, MPH
- Phone Number: 713-792-9599
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- University of Texas MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women with small cell carcinoma of the cervix who are members of a social networking support group on Facebook who give informed consent and are able to complete a 15 min online survey.
Exclusion Criteria:
- Women with small cell carcinoma of the cervix who are members of a social networking support group on Facebook who cannot respond to an English online survey.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Carcinomas of the Cervix Survey
Women with small and large cell carcinomas of the cervix, who are members of the Facebook group found at the uniform resource locator https://www.facebook.com/SmallCellCC
through an online link.
|
Completion of online surveys taking approximately 15 - 20 minutes.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of Using Social Networking Groups to Survey Patients with Rare Cancers.
Time Frame: 1 day
|
The entire study will be conducted electronically.
A survey assessing presentation of disease, treatment history and follow-up will be hosted on a secured online server.
In addition respondents will be asked to complete a battery of 40 questions assessing anxiety regarding their diagnosis and fear of recurrence based on previously published instruments.
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael M. Frumovitz, MD,MPH, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-0464
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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